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Statistical Analysis Plan for a Randomized Controlled Trial of Intensive Blood Pressure Control on Cardiovascular

Xiaolei Lin1, Chao Jiang2,3,4, Zhiyan Wang2,3,4

  • 1Data Science, Fudan University, Shanghai, China.

Cerebrovascular Diseases (Basel, Switzerland)
|September 2, 2025
PubMed

Insights

The Cardiovascular Risk Reduction in Atrial Fibrillation Trial (CRAFT) investigates if intensive blood pressure control (<120 mmHg) reduces cardiovascular events in atrial fibrillation patients compared to standard control (<135 mmHg). This study ensures transparent analysis through a pre-defined statistical plan.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Hypertension Management

Background:

  • Elevated blood pressure (BP) is a significant risk factor for cardiovascular (CV) complications in patients with atrial fibrillation (AF).
  • Current guidelines suggest moderate BP targets, but the optimal BP goal for AF patients remains unclear.
  • The Cardiovascular Risk Reduction in Atrial Fibrillation Trial (CRAFT) addresses this uncertainty.

Purpose of the Study:

  • To evaluate if intensive home systolic BP control (<120 mmHg) is more effective than standard BP control (<135 mmHg) in reducing major CV events in AF patients.
  • To compare the efficacy of two distinct BP management strategies in a high-risk population.

Main Methods:

  • A multicenter, prospective, randomized, open-label, blinded-endpoint trial design.
  • Enrollment of 1,675 participants to achieve 80% power for detecting a win ratio of 1.50.
  • Primary outcome: hierarchical composite of CV death, stroke, myocardial infarction, and heart failure hospitalization.

Main Results:

  • The primary outcome analysis will utilize the win-ratio method.
  • Secondary outcomes will be analyzed using Cox proportional hazards and Poisson regression.
  • Sensitivity analyses and missing data handling strategies are pre-specified.

Conclusions:

  • A pre-defined Statistical Analysis Plan (SAP) ensures transparency and verifiability of the CRAFT trial results.
  • The SAP was finalized prospectively, independent of treatment assignment, to maintain internal validity and minimize bias.
  • This rigorous approach aims to provide reliable evidence on optimal BP management in AF.
Abstract

Keywords:
Atrial fibrillationBlood pressureClinical trialHypertensionStatistical analysis plan

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